Current partner codePEPTIDESDE
NCT01673984·Phase 4·INTERVENTIONAL

GP Extended Action Triptorelin

Status

Terminated

Phase

Phase 4

Enrollment

27

Locations

35

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

Interventions

Treatment arms and agents.

DRUG

Decapeptyl® SR 22.5mg

22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).

DRUG

Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg

For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall

Timeline

From registration to results.

  1. First posted

    Aug 28, 2012

  2. Study start

    Aug 2012

  3. Primary completion

    Feb 2014

  4. Study completion

    Feb 2014

  5. Results posted

    Sep 29, 2015

  6. Registry updated

    May 23, 2025

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants Maintaining Biochemical Castration

Time frame · 6 months

Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.

Secondary outcomes

Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.

Time frame · 12 months

Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..

Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels

Time frame · 6 and 12 months

Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.

Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.

Time frame · Baseline and Month 12

The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).

Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)

Time frame · 6 and 12 month

TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.

Patient Satisfaction With Treatment.

Time frame · Month 12

Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.

Percentage of Participants Who Changed Injection Frequency After Completion of the Study

Time frame · Month 12

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * Patients must give written (personally signed and dated) informed consent before completing any study related procedure. * Patients must be 18 years old or over. * Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment * Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL * Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests * Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value). In addition: * For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline, * For patients with metastatic prostate cancer (M+) and a Gleason score \> 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline. * Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment. Exclusion Criteria: * Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions. * Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease). * Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma. * Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy. * Patients scheduled to receive palliative radiotherapy during the course of the study. * Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy. * Patients receiving LHRH agonist as adjuvant to surgery. * Patients scheduled to undergo radical prostatectomy during the course of the study. * Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.

Study locations

35 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

The Crouch Oak Family Practice

Addlestone, United Kingdom

Dr Carter & Partners

Ashford, United Kingdom

Westongrove Research Centre, Aston Clinton Surgery

Aylesbury, United Kingdom

Clinical Research Unit, Oldfield Surgery

Bath, United Kingdom

Clinical Research Unit, The Pulteney Practice

Bath, United Kingdom

St James' Surgery

Bath, United Kingdom

Waterloo Medical Centre

Blackpool, United Kingdom

Woolpit Health Centre

Bury St Edmunds, United Kingdom

Cossington House Surgery

Canterbury, United Kingdom

Research Office, Avondale Surgery

Chesterfield, United Kingdom

Clinical Research Dept., Rowden Surgery

Chippenham, United Kingdom

Clinical Research Unit, Hathaway Medical Centre

Chippenham, United Kingdom

The Porch Surgery

Corsham, United Kingdom

Pound Hill Surgery

Crawley, United Kingdom

The Medical Centre

East Horsley, United Kingdom

Burbage Surgery

Hinckley, United Kingdom

The Portmill Surgery

Hitchin, United Kingdom

Townhead Surgery

Irvine, United Kingdom

Mortimer Surgery

Mortimer Common, United Kingdom

Kiltearn Medical Centre

Nantwich, United Kingdom

Danes Camp Surgery

Northampton, United Kingdom

Kingsthorpe Medical Centre

Northampton, United Kingdom

Cape Cornwall Surgery

Penzance, United Kingdom

The Alverton Practice

Penzance, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Triptorelin.

Related PeptideStat pages

Put the record in context.

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